SUCCINYLCHOLINE CHLORIDE injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF)

Disponible depuis:

Devatis, Inc.

Mode d'administration:

INTRAMUSCULAR

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

SUCCINYLCHOLINE CHLORIDE INJECTION, USP is indicated in adults and pediatric patients: - as an adjunct to general anesthesia. - to facilitate tracheal intubation. - to provide skeletal muscle relaxation during surgery or mechanical ventilation. SUCCINYLCHOLINE CHLORIDE INJECTION, USP is contraindicated: - in patients with skeletal muscle myopathies [see Warnings and Precautions (5.1)] - in patients with known hypersensitivity to succinylcholine. Severe anaphylactic reactions to succinylcholine have been reported [see Warnings and Precautions (5.2)] - after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see Warnings and Precautions (5.4)] - in patients with known or suspected genetic susceptibility to malignant hyperthermia [see Warnings and Precautions (5.5), Clinical Pharmacology (12.5)] Risk Summary Available data from published literature from case reports a

Descriptif du produit:

SUCCINYLCHOLINE CHLORIDE INJECTION, USP is supplied as a clear, colorless solution in the following concentrations and packages: Refrigeration of undiluted SUCCINYLCHOLINE CHLORIDE INJECTION, USP will assure full potency until expiration date. Single-dose Fliptop Vials: Discard unused portion. Store in refrigerator 2 °C to 8 °C (36 °F to 46 °F). The multiple-dose vials are stable for up to 14 days at room temperature without significant loss of potency. Distributed by Devatis, Inc. San Clemente, CA 92672 For more information, contact Devatis, Inc. at 1-833-Devatis.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION
DEVATIS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO
USE SUCCINYLCHOLINE CHLORIDE INJECTION SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR SUCCINYLCHOLINE CHLORIDE
INJECTION.
SUCCINYLCHOLINE CHLORIDE INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR
USE
INITIAL U.S. APPROVAL: 1952
WARNING: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM
HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
ACUTE RHABDOMYOLYSIS WITH HYPERKALEMIA FOLLOWED BY VENTRICULAR
DYSRHYTHMIAS,
CARDIAC ARREST, AND DEATH HAS OCCURRED AFTER USE IN APPARENTLY HEALTHY
PEDIATRIC
PATIENTS WHO WERE SUBSEQUENTLY FOUND TO HAVE UNDIAGNOSED SKELETAL
MUSCLE
MYOPATHY. (5.1)
WHEN A HEALTHY-APPEARING PEDIATRIC PATIENT DEVELOPS CARDIAC ARREST
SOON AFTER
ADMINISTRATION OF SUCCINYLCHOLINE CHLORIDE INJECTION, USP, NOT FELT TO
BE DUE TO
OTHER CAUSES, IMMEDIATE TREATMENT FOR HYPERKALEMIA SHOULD BE
INSTITUTED. IN THE
PRESENCE OF SIGNS OF MALIGNANT HYPERTHERMIA, APPROPRIATE TREATMENT
SHOULD BE
INSTITUTED CONCURRENTLY. (5.1)
RESERVE USE OF SUCCINYLCHOLINE CHLORIDE INJECTION, USP IN PEDIATRIC
PATIENTS FOR
EMERGENCY INTUBATION OR INSTANCES WHERE IMMEDIATE SECURING OF THE
AIRWAY IS
NECESSARY, OR FOR INTRAMUSCULAR USE WHEN A SUITABLE VEIN IS
INACCESSIBLE. (5.1)
RECENT MAJOR CHANGES
Contraindications (4) 11/2022
Warnings and Precautions (5.5) 11/2022
INDICATIONS AND USAGE
SUCCINYLCHOLINE CHLORIDE Injection, USP is a depolarizing
neuromuscular blocker indicated in adults
and pediatric patients:
as an adjunct to general anesthesia. (1)
to facilitate tracheal intubation. (1)
to provide skeletal muscle relaxation during surgery or mechanical
ventilation. (1)
DOSAGE AND ADMINISTRATION
For intravenous or intramuscular use only. (2.1)
Individualize dosage after careful assessment of the patient. (2.1)
Accidental administration of neuromuscular blocking agents may